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Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes

This study has been completed.
Sponsor:
Information provided by:
Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:
NCT00622752
First received: February 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short term deprivation of cigarettes.


Condition Intervention Phase
Smoking Cessation
Drug: EVT 302, 10 mg
Drug: placebo
Drug: Nicotine replacement therapy (NRT)
Device: NRT placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo- and NRT -Controlled Phase II Study to Assess the Effects of EVT 302 Alone and in Combination With NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes

Resource links provided by NLM:


Further study details as provided by Evotec Neurosciences GmbH:

Primary Outcome Measures:
  • Reduction in Craving and withdrawal [ Time Frame: Within 12 hours of the last cigarette ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CogState Cognitive test Battery [ Time Frame: 12 hours post last cigarette ] [ Designated as safety issue: No ]
  • Breath carbon monoxide levels [ Time Frame: 12 hours post last cigarette ] [ Designated as safety issue: No ]
  • Salivary cotinine levels [ Time Frame: 12 hours post last cigarette ] [ Designated as safety issue: No ]
  • Clinical safety lab tests [ Time Frame: Up to 7 days post dose ] [ Designated as safety issue: Yes ]
  • Assessment of adverse events [ Time Frame: Up to 7 days post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
EVT 302, 10 mg
Drug: EVT 302, 10 mg
2 X EVT 302, 5 mg tablets
Experimental: 2
EVT 302, 10 mg + NRT patch, 21 mg
Drug: EVT 302, 10 mg
2 X EVT 302, 5 mg tablets
Drug: Nicotine replacement therapy (NRT)
NRT patch containing 21 mg of nicotine
Experimental: 3
NRT patch, 21 mg
Drug: Nicotine replacement therapy (NRT)
NRT patch containing 21 mg of nicotine
Placebo Comparator: 4
Placebo to match EVT 302 and placebo patch to match NRT patch
Drug: placebo
2 X placebo tablets to match EVT 302 5 mg
Device: NRT placebo
Medically inert plaster cut to match the NRT plaster

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects between 18 and 55 years of age, inclusive
  • BMI between 18 and 30, minimum weight of 50 kg
  • Negative urine drug & alcohol screen
  • Able to comply with tyramine-restricted diet
  • Smoking of ≥17 and ≤34 cigarettes per day for the past year and have not tried to quit smoking in the 3 months prior to screening
  • Subjects are willing and able to quit for about 12 hours in each of three subsequent study periods
  • Previous experience of craving following smoking cessation
  • Breath CO between 15 ppm and 20 ppm and cotinine in saliva and plasma at least 250 ng/mL at screening
  • Liver function test results not above 1.5 times the upper normal limit (UNL) at screening visit and at re-assessment during the study.

Exclusion Criteria:

  • Participation in another clinical study within 60 days of screening
  • Evidence of active significant psychiatric or neurological disease or dependency other than cigarettes
  • Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, has a positive result to the human immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies
  • Known hypersensitivity to MAO inhibitors or any substance that is contained in the study formulations
  • Known allergy to plasters or NRT patches
  • Previous participation in another study with EVT 302
  • Currently receiving treatment for smoking cessation
  • Current use of tobacco products other than cigarettes
  • Require treatment with any medication
  • Subject with a clinically relevant abnormal 12-lead ECG recording or QTcB/F >430 ms
  • Use of a prescription medicine within 14 days or 5 half-lives, whichever is the longer, of the start of dosing, or use of an over-the-counter medication during the 7 days before the study, including herbal remedies, but excluding paracetamol and vitamin supplements (provided intake does not exceed the daily recommended allowance)
  • Subjects must not be planning to father a child or donate sperm, during the study and 3 months after the end of the study. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least 2 month)
  • Daily consumption of more than 5 cups of tea or coffee, or more than 1.0 litre of xanthine-containing drinks
  • Recent myocardial infarction, unstable or worsening angina pectoris, prince metal angina, severe arrhythmias, recent stroke.
  • Creatinine clearance (CLR) calculated according to the formula by Modification of Diet in Renal Disease (MDRD) of <80 mL/min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622752

Locations
Germany
PAREXEL International GmbH, Clinical Pharmacology Research Unit
Berlin, Germany, 14050
Sponsors and Collaborators
Evotec Neurosciences GmbH
Investigators
Principal Investigator: Alla Radicke, MD Parexel International GmbH, Clinical Pharmacology Research Unit
  More Information

No publications provided

Responsible Party: Doris Greiling, Clinical Development Programme Manager, Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier: NCT00622752     History of Changes
Other Study ID Numbers: EVT 302/3011, EUDRACT No.: 2007-006236-63
Study First Received: February 13, 2008
Last Updated: June 16, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Evotec Neurosciences GmbH:
Smoking cessation
Craving
Smokers

ClinicalTrials.gov processed this record on November 25, 2014